EP2433591A2 - Apparatus for holding an annuloplasty ring - Google Patents
Apparatus for holding an annuloplasty ring Download PDFInfo
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- EP2433591A2 EP2433591A2 EP11194544A EP11194544A EP2433591A2 EP 2433591 A2 EP2433591 A2 EP 2433591A2 EP 11194544 A EP11194544 A EP 11194544A EP 11194544 A EP11194544 A EP 11194544A EP 2433591 A2 EP2433591 A2 EP 2433591A2
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- European Patent Office
- Prior art keywords
- ring
- holder
- shaped
- bracket
- annuloplasty ring
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- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
- A61F2/2445—Annuloplasty rings in direct contact with the valve annulus
- A61F2/2448—D-shaped rings
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
- A61F2/2466—Delivery devices therefor
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- Health & Medical Sciences (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Prostheses (AREA)
- Materials For Medical Uses (AREA)
Abstract
Description
- This application claims the benefit of
U.S. provisional patent application No. 60/571, 020, filed May 14, 2004 - This invention relates generally to holding devices for implantable medical prostheses or devices, and more specifically to holding devices for securing and supporting annuloplasty rings to be implanted adjacent to mitral or tricuspid valves.
- Annuloplasty rings are useful in a variety of medical procedures, such as strengthening the base annulus of mitral and tricuspid valves in the heart. Heart disease may result in disorders of the cardiac valves characterized by weakening or loosening of the heart muscle tissue forming and surrounding the heart valves. The mitral and tricuspid valves respectively allow blood to flow from the heart's left and right atria into the heart's left and right ventricles. Weakening of heart tissues may cause these valves to function improperly. In particular, these valves may no longer close completely, allowing blood to be regurgitated back through the valve during ventricle contraction. An annuloplasty ring may be used to provide support to the base annulus of a cardiac valve, restoring the ability of the valve to close and seal itself adequately. The ring prevents the base annulus of the valve from deforming, thereby reducing or eliminating regurgitation through the valve.
- The implantation of an annuloplasty ring on a cardiac valve may require open-heart or less invasive surgery. During surgery, the implanted ring is mounted on a specially designed holder which is used to secure and maintain the shape of the ring while the ring is placed into the heart and is sutured to the valve annulus. The holder may also be used to secure and support the ring during storing, transportation, and other manipulations surrounding the implantation procedure. The holder is typically detached from the ring during the ring implantation procedure, and is removed from the implantation site.
- U.S. Pats. No. 5,041,130, No. 5, 011, 481, and No. 6,001,127 show and describe annular and C-shaped annuloplasty ring holders.
- The present invention provides apparatus and methods for securing and supporting annuloplasty rings during implantation of the rings and during related procedures. The apparatus may include a specially designed holder to which the ring can be releasably secured.
- The holder may be planar or saddle-shaped, and may be shaped so as to approximate the shape of the implanted ring. The holder may also be flexible or semi-flexible. The holder may include holes or be structured so as to increase the visibility of the valve and surrounding area through or around the holder. A connector may be mounted on the holder to allow the holder to be manipulated by the physician. The connector may be placed, shaped, or recessed so as to increase visibility of the operative area, to improve access to the area, or to suit other objectives.
- The ring may be secured to the holder using a variety of means and methods. Suture threads may be used to tie the ring to the holder. Threads may be stitched through, or looped or wrapped around either or both of the ring and holder. Suture threads may be released using cutting blocks indicating locations for or guiding the cutting of the threads. Cutting blocks may be located or recessed at various locations on the holder, may be shaped to suit a variety of objectives, and may incorporate knot tying posts where suture thread may be tied. Suture threads may also be released using other methods. The ring may also be secured to the holder using internal tension or clamping means. A variety of holders functioning on these principles are presented.
- Further features of the invention, its nature, and various advantages will be more apparent from the following detailed description and the accompanying drawings, in which:
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FIG. 1 is a side view of an illustrative planar annuloplasty ring holder in accordance with the invention. -
FIG. 2 is a top view of a planar annuloplasty ring holder similar to that shown inFIG. 1 . -
FIG. 3 is a side view of an illustrative saddle-shaped annuloplasty ring holder in accordance with the invention. -
FIG. 4 is a top view of a saddle-shaped annuloplasty ring holder similar to that shown inFIG. 3 . -
FIG. 5 is a top view of another illustrative annuloplasty ring holder in accordance with the invention. -
FIG. 6 is a top view an illustrative annuloplasty ring holder attached to an annuloplasty ring, in accordance with the invention. -
FIG. 7 is a side view of an illustrative planar annuloplasty ring holder with a shortened connector stub, recessed connector base and recessed cutting blocks, in accordance with the invention. -
FIG. 8 is a side view of an illustrative saddle-shaped annuloplasty ring holder with a recessed connector base, in accordance with the invention. -
FIG. 9 is a side view of an illustrative saddle-shaped annuloplasty ring holder with a recessed connector base, in accordance with the invention. -
FIG. 10 is a top view of an illustrative planar annuloplasty ring holder indicating the location (at line 11-11) of the cross-sectional view shown inFIG. 11 , in accordance with the invention. -
FIG. 11 is an oblique, cross-sectional view of a planar annuloplasty ring holder taken along the line 11-11 inFIG. 10 , in accordance with the invention. -
FIGS. 12a-12c are a series of three cut-away views of an illustrative annuloplasty ring holder including knot tying posts in accordance with the invention. -
FIGS. 13a-13c show three illustrative suture thread wrapping methods in accordance with the invention. -
FIGS. 14a and 14b show an illustrative annuloplasty ring holder with releasable suture threads in accordance with the invention. -
FIGS. 15 is a schematic depiction of an illustrative internal tension annuloplasty ring holder in accordance with the invention. -
FIGS. 16a and16b are two views of an illustrative internal clamping annuloplasty ring holder in accordance with the invention. -
FIGS. 17a and17b are two views of an illustrative internal clamping annuloplasty ring holder in accordance with the invention. -
FIG. 18 is a schematic depiction of serrated clamps that may be included in an annuloplasty ring holder in accordance with the invention. -
FIGS. 19a and 19b show an illustrative end-clamping annuloplasty ring holder in accordance with the invention. -
FIGS. 20a and 20b show an illustrative internal tension annuloplasty ring holder with retractable pins in accordance with the invention. -
FIG. 21 is a schematic depiction of illustrative clamping brackets that may be included in an annuloplasty ring holder in accordance with the invention. -
FIGS. 22a and22b show an illustrative clamping annuloplasty ring holder in accordance with the invention. -
FIGS. 23a and 23b respectively show schematic depictions of an illustrative clamping annuloplasty ring holder and an illustrative non-thread holder in accordance with the invention. -
FIG. 24 is a schematic depiction of an illustrative sheath holder in accordance with the invention. -
FIGS. 25a and25b show an illustrative annuloplasty holder and ring with pre-stitched sutures in accordance with the invention. - This invention describes embodiments of a holder for an annuloplasty ring. An annuloplasty ring may be used by a surgeon to assist in strengthening or reshaping a heart valve. An annuloplasty ring may be sutured to the heart adjacent to, for example, the mitral valve to reshape the valve. This procedure may be used to treat and limit valve regurgitation, or any other valve malfunction. Before and during implantation of the annuloplasty ring into the patient, the ring is mounted on a holder which is used to secure and support the ring as it is placed and sutured into the heart. The holder may be stiff or flexible, and may alternatively be used during open-heart or minimally invasive surgery. A flexible holder may be especially well suited for minimally invasive surgery, during which the holder and ring may have to be inserted into the patient's heart through a catheter. The holder may also be used to support the ring during storage, manipulation or other procedures surrounding annuloplasty ring implantation and preparation. In a preferred embodiment, the holder is not implanted into the patient. Instead, the holder is detached from the ring during the implantation procedure and is removed from the implant site. The ring holder may be manipulated by the surgeon using a handle or other grasping device that attaches to a connector included on the ring holder.
- The following specification describes various novel features that may be incorporated into a ring holder. These features may include, for example, alternate holder structures, connector structures, cutting blocks and suture tying posts, suture and non-suture methods of attaching the ring to the holder, as well as pre-stitched sutures. Such features are described in the associated titled sections of the following description.
- Those skilled in the art will appreciate that while the invention is described with regard to holders specifically designed for annuloplasty rings, the invention may be used in the more general context of designing mounting brackets for a variety of medical and other applications.
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FIGS. 2 ,4 , and5 show top views of illustrativeannuloplasty ring holders holders holders connectors 15, 35, and 55. Each of these features will be discussed in more detail in following sections of this description. - The center of the
annuloplasty ring holder open areas multiple holes 13 pierced through the upper surface of the holder, or by a single largecentral hole - The center of the holder may contain at least one
connector 15, 35, or 55. The connector is represented by a hexagonal stub in the accompanying figures. The connector may be used to attach the holder to a handle or other grasping device used by the surgeon to grasp and manipulate the holder. The connector is typically located along thebracket 31 or 51, or in the central portion of thebracket 11 with support arms connecting it to the outer bracket. The connector may also be located elsewhere on the ring holder. In a preferred embodiment, the location of the connector is determined so as to be accessible to the surgeon, and to provide easy and skillful manipulation of the ring and holder when a handle or other device is attached to the connector. The location of the connector may also be determined so as to increase the visibility of the heart valve area to the physician, and to decrease the cluttering of the operating area. Other requirements may also influence the location of the connector on the annuloplasty ring holder. In the illustrative embodiments shown inFIGS. 2 ,4 , and5 , theconnector 15, 35, or 55 is alternately located in the middle of thebracket 11, or placed along the edge of thebracket 31 or 51 so as to provide a continuousopen area bracket bracket 50. The connector may also be located along the edge ofbracket 11, in the center ofbrackets 31 or 51, or at any other location onholders -
FIGS. 1 and3 show side views ofannuloplasty ring holders holder 10 may be planar, as shown inFIG. 1 . A planar holder may have an essentiallyflat bracket 11. Theholder 30 may alternatively be saddle-shaped, to more closely follow and support the shape of a saddle-shaped ring. A saddle-shaped ring holder may have anon-planar bracket 31, and may be used to secure and support essentially saddled-shaped annuloplasty rings. Saddle-shaped rings may more closely follow the natural shape of the base of the heart valve (e.g., the mitral valve), and may thus further improve the functioning of the valve after implantation of the ring. The saddle of the ring holder may be symmetrical on the posterior and anterior section of the holder. The saddle may have varying height, typically in the range of 2mm to 10mm from the lowest to highest points on the holder (corresponding to an Annular Height to Commissure Width Ratio (AHCWR) in the range from about 5% to about 25%). - The ring holder may incorporate other features to aid the physician during the ring implantation procedure.
FIG. 6 shows aring holder 60 withindicator tabs 66. An annuloplasty ring 62 is shown attached to thering holder 60. Theindicator tabs 66 indicate the trigone locations, and help the physician to align the ring on the heart valve with ease and precision. The indicator tabs may be printed molded, or other visual indications placed on the ring or ring holder, which help align the ring and holder on the heart valve. Indicator tabs may also assume other forms. - The annuloplasty ring 62 shown in
FIG. 6 may be a full circular ring (as shown), a circular ring with a gap (a gapped ring), or a C-shaped prosthesis, among others. For simplicity, the term 'ring' is used herein to refer to any annuloplasty ring embodiment. Note that while either full circular or C-shaped rings are alternatively shown in the accompanying figures, the holders, features and embodiments described herein may be used with any type of ring, except in those cases where it is specified otherwise. - The
connector 15, 35, or 55, is a part of the holder which can be used to attach the holder to a handle or other grasping instrument (not shown). The physician may attach a handle or grasping instrument to the connector in order to manipulate the holder and ring assembly, and to place them at an implant or other appropriate site. The connector may include features allowing it to be grasped using fingers, forceps, or other means, or secured using a snap fit, screw thread, twist pin or other means of connecting a handle. The connector may also include permanent attachments, in cases in which the holder and handle or grasping instrument are a single entity. In the figures, the connector is illustratively represented as a hexagonal stub. This does not preclude use of a different non-hexagonal connector. - As noted above, and as illustrated in
FIGS. 2 ,4 , and5 , the location of the connector on the holder may be varied to suit a variety of objectives. The connector may be placed in such a way as to maximize the physician's visibility of the implanted ring, of the heart valve, and of the operative area surrounding these structures. The connector may also be placed in such a way as to maximize the physician's ability to place and otherwise manipulate the ring and holder with accuracy, to maximize the physician's access to the operative area, and to minimize cluttering of the operative region with the handle or grasping device used to manipulate the holder. Other objectives may also influence the positioning of the connector on the holder. - The position of the connector in the holder's horizontal plane was discussed above in the context of
FIGS. 2 ,4 , and5 . The following paragraphs describe varying the position and height of the holder in the vertical direction. -
FIG. 1 shows aplanar ring holder 10 with aconnector 15 whose bottom surface is flush with thelower surface 14 of the holder. Theconnector stub 15 protrudes above theupper surface 12 of the holder, while the base of the connector is flush with thelower surface 14 of the holder. Theplanar ring holder 70 shown inFIG. 7 shows a recessedconnector base 78 whose lower surface is lower than thelower surface 74 of the holder. The recessedconnector base 78 may jut down below theholder bracket 71, jutting down into the valve orifice when the holder and ring are place at the implant site. Thering holder 70 may also employ a shortenedconnector stub 75 which is shorter than a full-length connector structure 15 and protrudes less from the holder. In another embodiment, theconnector base 78 may be further recessed into theholder 70, or theconnector stub 75 further shortened, so as to reduce the protrusion of the connector structure from thering holder 70. The shortening of theconnector stub 75 and the lowering of theconnector base 78 provide better access and visibility along the upper portion of the holder. By reducing or eliminating the protrusion of theconnector stub 75 above thebracket 71, the physician may have more space to tie the implanting suture knots, or to perform other manipulations along the periphery of the ring. The reduced protrusion of thestub 75 may also improve the physician's view of the periphery of the ring and other adjoining structures. -
FIGS. 8 and 9 show similarly recessed and shortenedconnectors first embodiment 30 of a saddle-shaped holder shown inFIG. 3 , theconnector base 38 is approximately level with the highest point reached by thelower surface 34 of theholder bracket 31. The connector stub 35 protrudes above the highest point reached by theupper surface 32 of the bracket. In asecond embodiment 80, theconnector base 88 is lower than in thefirst embodiment 30. This causes theconnector stub 85 to protrude less above theupper surface 82 of holder bracket 81, increasing visibility above theholder 80. Similarly, in athird embodiment 90,connector base 98 is further recessed.Connector stub 95 protrudes less above the upper surface 92 ofbracket 91. In fact, inthird embodiment 90, theconnector stub 95 is almost flush with the upper surface 92 of thebracket 91. In both the second and third embodiments, the recessedconnector stub bases holders connector stubs holder brackets 81 and 91. Note that while shortened connector stubs such asstub 75 are not shown inFIGS. 3 ,8, and 9 , shortened connector stubs may be used in combination with saddle-shaped holders to reduce protrusion of the stub above the bracket. Shortened stubs may also be used to reduce the jutting out ofconnector bases bracket 81 and 91. - Before and during the implantation procedure, the annuloplasty ring may be secured to the holder. The holder may be used to hold and manipulate the ring as it is placed at the implant site, and to support the ring during handling and while the ring is sutured into place. The holder may be detached from the ring during the implantation procedure, because the holder is typically not implanted with the annuloplasty ring into the heart. The ring may be secured to the holder using a variety of means. The ring may be attached to the holder using suture thread, or other thread-like structures. Alternatively, the ring may be attached to the holder using other releasable means. Various methods that may be used to secure the ring to the holder are described in more detail later in this specification.
- In embodiments of this invention in which annuloplasty rings are secured to the ring holder by suture threads or other means amenable to cutting, cutting blocks may be included on the holder. Cutting blocks are guides used to facilitate the cutting of suture threads or other means of attaching an implanted annuloplasty ring to a holder. Cutting blocks may be used to help the physician locate the appropriate suture threads to cut, to ensure that the physician cuts the proper threads, and to prevent the physician from cutting tissue or sutures other than those passing through the cutting block.
- Cutting blocks may include visual or other guides indicating to the physician the preferred location or locations where a suture thread used to attach the ring to the holder may be cut. In this way, cutting blocks may be used to identify those sutures that should or can be cut to release the ring from the holder. Cutting blocks may include painted, molded, or other visual indications highlighting the locations of preferred cutting locations. Cutting blocks may also include physical guides that direct or steer in other ways the physician to a preferred cutting location. In a preferred embodiment, the cutting blocks may include slots or other guiding means used to direct the physician's scalpel blade and ensure that the appropriate suture thread is cut.
- Cutting blocks may be located at a variety of locations on the ring holder. In the particular embodiment shown in
FIG. 10 , four cuttingblocks 107 are placed at various location on the holding bracket 101. In the embodiment shown inFIG. 4 , three cuttingblocks 37 are located onbracket 31. Holders with more or fewer cutting blocks, or cutting blocks placed at different locations on the bracket or on the holder, may also be used. As in the case of connector locations, cutting blocks may be placed in the center of the bracket, if appropriate, with support structures holding the cutting block in place with respect to the bracket. - The location of cutting blocks may also be varied in the vertical holder plane. Cutting blocks, which include cutting slots, have non-negligible depths. Such cutting blocks may be thicker than the
holder brackets FIG. 1 holder 10shows cutting blocks 17 protruding above theupper surface 12 ofbracket 11. The cutting block may be recessed, as shown inFIG. 7 . In the holder embodiment ofFIG. 7 , cutting blocks 77 do not protrude above theupper surface 72 ofbracket 71. Instead, cutting blocks 77 protrude below thelower surface 74 ofbracket 71. Recessed cutting blocks 77 may protrude into the valve tissue and valve orifice found below the ring implantation site. However, recessed cutting blocks 77 provide better visibility along theupper surface 72 ofholder 70, giving the physician an unobstructed view of the implanted ring and structures adjacent to the implant site. While recessed cutting blocks 77 are shown inFIG. 7 in the particular context ofplanar holder 70, recessed cutting blocks may be included on saddle-shaped holders, or other types of implant device holders. -
FIGS. 10 and 11 show two views of an illustrative annuloplasty ring holder that includes cutting blocks.FIG. 10 shows a top-down view of aholder 100, showing the plane of section 11-11 illustrated in the cross-sectional view ofFIG. 11 .
The cross-sectional view ofFIG. 11 shows a cut-away view through a cutting block. As seen inFIG. 11 , each cuttingbLock 107 may include a slit into which a scalpel blade may be introduced, and twoholes 109 through which suture thread may pass. The axis of the holes intersects the axis of the cutting slit, so that a thread passing through the holes crosses the cutting slit. The thread may cross at approximately half the slot depth. When a scalpel is passed through the cutting slit, the suture thread is cut, releasing at least one section of the ring from the holder. - The cutting slit shown in cross-sectional view 11-11 of cutting
block 107 may have an asymmetrical half-moon shape. The cutting slit may be shaped to match the shape of the scalpel blade, in order to increase cutting efficiency. The shape of the slit may also be designed to guide cutting in a preferred direction, or to permit cutting in both directions. The shape may also be adjusted to draw the cutting action upward and away from the tissue, minimizing the risk of damaging structures surrounding the implant site. In the particular example shown inFIG. 11 , the cutting slit may match the shape of a #15 scalpel blade. Slits may be shaped to match other standard scalpel blades. - Annuloplasty ring holders may include knot tying posts on which suture threads used to hold the ring to the holder may be knotted. The knot tying posts may be placed next to cutting blocks, as the suture thread may pass through both structures. As shown in
FIGS. 12a-12c , thethread 123 may pass through the annuloplasty ring and the cutting block'ssuture channels 129, and have at least one of its ends knotted 124 to aknot tying post 128. Both ends of the thread may also be knotted 124 to each other and to theknot tying post 128, as shown inFIGS. 12a-12c . The knot tying post may be used to hide sutures used to hold the ring to the holder underneath the holder's upper surface. As such, knot tying posts may be located on the lower side of the holder, so as to reduce visual distractions on the holder's upper surface. The knot tying post may also be used to ensure the suture thread does not remain attached to the implanted annuloplasty ring after the ring is released from the holder. To this end, both ends of the suture thread may be tied to a knot tying post, thereby ensuring that both portions of the cut thread remain attached to the holder when the holder is removed from the implant site.Knots 124 may be tied on each side of the post, as shown onknot tying post 128, to retain suture after it is cut. - Various methods may be used to secure the annuloplasty ring to the ring holder. Methods involving suture thread, or other thread-like implements, may be used to tie the ring to the holder. Alternatively, other retaining means may be used to secure the ring to the holder. These may include clamping devices or other restraining devices incorporated into the holder. Such devices are described in further detail in the following two sections of this description.
- The annuloplasty ring may be attached to the ring holder using suture thread, or similar thread-like implements. The suture thread may pass through the holder, may be looped around the holder, or may be attached to the holder in other ways.
FIG. 6 shows an exemplary arrangement in which the thread 63 passes throughsuture channels 69 on the holder bracket 61. Thesuture channels 69 may be located at various locations on theholder 60, in order to ensure that the ring 62 can be held firmly against the holder bracket 61. In the particular embodiment shown inFIG. 6 , a single length of suture thread 63 may be looped multiple times through theholder 60 and around the ring 62. By looping the thread around the ring and holder assembly multiple times, fewer threads may be needed to hold the ring attached to the holder, because each length of thread secures the ring on the holder in multiple locations. In such an embodiment, fewer cutting blocks may be required because each length of thread need only be cut in one location. In the particular embodiment ofFIG. 6 , the ring 62 is retained by the thread 63 using forces pulling inward in the radial direction. The overhang of the holder bracket may therefore be reduced, improving access to the ring periphery and to the surgeon's suturing positions on the ring. - The suture thread may also be looped around the holder, with or without passing through suture channels on the holder. Such an embodiment is shown for example in
FIGS. 14a and 14b . In this embodiments, thesuture thread 143 may not pass through theholder bracket 141. Instead, the threads may be held taut against the edges of the bracket. Different means of wrapping the suture thread around the holder and bracket may be used. For example, means similar to those used to secure the ring described in the following section may also be used to secure the suture thread to the holder. - In embodiments in which suture thread is used to secure the ring to the holder, the suture thread may be secured to the annuloplasty ring by passing through the ring, by looping around the ring, or by holding the ring to the holder in other ways. In one illustrative embodiment shown in
FIG. 13a , thethread 133 may be passed one or more times through thering 131 in a through stitch. The same thread may also pass through or wrap around thering holder 132, as described in previous sections of this description. - The thread may also wrap around the
annuloplasty ring 131, with or without being stitched through the ring.FIG. 13b shows athread 134 looping a single time around thering 131 in one embodiment, andFIG. 13c shows athread 135 wrapped multiple times around thering 131 in a second embodiment. By wrapping thethread 135 multiple times around the ring and holder, a single length of thread can be used to secure a wider section of the ring against the holder than asingle loop 134 of thread can secure. Wrapping thethread 135 multiple times around the ring and holder may reduce the total number of threads, cutting blocks, tying posts and other holder structures that may be used to hold the ring attached to the holder. By looping or wrapping the thread around the ring, the thread may pull the ring radially inward against the holder bracket. In such an embodiment, the holder bracket can have minimal overhang above and below the ring, supplying instead an inner support structure against which the ring is held. This may improve access to the ring's outer periphery, improving the physician's view and access to the ring periphery. Alternatively, the looping or wrapping of the thread around the ring can be used to pull the ring upward against a holder bracket placed substantially around the ring's upper surface. Such a holder may have fewer bracket structures in its center, providing the physician with an unobstructed view of the heart valve region through the center of the holder. - In embodiments in which suture methods are used to secure the ring to the holder, the thread or threads used to secure the ring may be cut to release the ring from the holder. The cutting may be performed using a scalpel, cutting blocks, or other appropriate cutting methods. Other methods may also be used to release the ring from the holder.
FIGS. 14a and 14b show a push-button release method for disengaging thethread 143 and releasing thering 142. The push-button 144 may be used to release one or multiple threads concurrently. Releasing of the ring may require one or multiple push-buttons to be pressed. - Other methods may be used to secure the ring to the holder. These methods may use internal tension, clamping, or other means to hold the ring.
-
FIGS. 15 through 20 show a series of illustrative holders that use internal tension or internal clamping to hold the ring. These holders may have braces that can extend or retract in the radial direction. When the braces are extended outwards, friction or internal tension forces between the brace and the ring may secure the ring to the holder. Alternatively, or in addition to internal tension, brace structures may be used to hold the ring. -
FIG. 15 shows a basicinternal tension holder 152 holding ring 151.Holder 152 may be stiff or elastic, and may include central structures to maintain its shape and elasticity, or to attach a connector. A flexible orsemi-flexible holder 152 may be used to support D-shaped rings. In such a case, the natural shape adopted by the holder and ring assembly when internal tension is applied may be a saddle-shape. In general, ring 151 may be a complete annuloplasty ring. Ring 151 may also be a C-shaped (as shown) or gapped ring, which may require a stiff orelastic suture thread 153 to be tied between the ends of the ring.Suture thread 153 may serve to maintain the ring's shape, and to keep the ring on the holder.Holder 152 may be an flexible holder. -
FIGS. 16 and17 show holders with C-shapedbraces 161 and 171. The beveled edges of the braces may serve to support the ring, and to keep it from slipping out of the holder when the braces are extended radially outward. Serrated, high friction, or clipping brackets may also be used to further secure the ring in the brackets.FIG. 18 shows one schematic embodiment of serrated clip brackets 182 holding ring 181. The clip brackets may have hinged jaws that can alternately clamp and hold the ring, or open and release the ring from the holder. - The holders may also have a release mechanism used to disengage the braces securing the ring. The release mechanisms may include a push-button or other type of mechanism which may be used to draw the braces inward, releasing the ring from the holder.
FIGS. 16 and17 show two exemplary release mechanisms in which a push-button or lever placed at or near the center of the holder is used to retract the braces. The release mechanisms shown in these figures are exemplary, and other known types of release mechanisms may be used in these holders. The braces may be retracted by moving upper and lower sets of radialbracket support arms support arms support arms braces 161 and 171 radially inward, and to release the ring from the holder, -
FIGS. 19a and 19b show an exemplary holder that uses end-clamps 192 to hold a C-shaped prosthesis ("ring") to the holder. The end-clamps 192 latch onto thering 191, while beveled edges on the bracket may assist in securing the ring. The end-clamps may be disengaged as shown at 193 when the ruing is released from the holder. A C-shaped holder may fold onto itself, as shown inFIG. 19b , to release thering 191 from itsouter brackets 194. -
FIGS. 20a and 20b show anexemplary holder 200 that has retractable rods or pins 202 sticking radially out of acentral holder structure 203. The rods or pins may be made of stiff or flexible materials, and may be made of shape memory alloy or nitinol. When engaged, therods 202 extend radially outward from thecentral structure 203 and exert pressure at multiple points on the ring's inner surface. When disengaged, therods 202 retract inward and release thering 201 from theholder 200. The rods may be disengaged by rotating acentral hub 203 into which therods 202 are inserted. Other disengagement mechanisms may also be used. -
FIGS. 21 and22 show clamping or clamshell holders. These holders may include one or morecentral braces 212 or 222, as well as one or more retractableouter supports ring 211 or 221 in one or more locations around the ring. The braces may have beveled edges or protrusions to inhibit the ring from slipping out of the clamp. The clamping brace may release the ring by moving the inner and outer clamping braces apart. In one embodiment shown inFIGS. 22a and22b , theouter braces 223 may be released, while the inner braces 222 may remain substantially stationary. In another embodiment, the outer braces may remain substantially stationary while the inner braces retract. Alternatively, both the inner and outer braces may move. The holder may release the ring using a push-button mechanism, or other mechanisms. In the particular embodiment shown inFIGS. 22a and22b , the ring is released from the holder by applying a twisting action of a central portion of the holder, and disengaging the outer clamping orclamshell structures 223. The outer clamping orclamshell structures 223, once disengaged, may move freely and release thering 221. Other known release and clamping mechanisms may also be used. - Clamping and other methods used to secure the ring into the holder may be combined with other retaining means.
FIG. 23a showsring 231 secured toholder 232 using clamp-like structures 233. Clamp-like structures 233 may comprise a variety of materials including thread, cloth, metallic, and/or plastic, among others. The clamp-like structure 233 may be held in place bysuture thread 234. Clamp-like structure 233 may be released by cuttingsuture thread 234.FIG. 23b showsring 231 secured toholder 232 using anon-thread wrap 235.Non-thread wrap 235 may be of any of a variety of materials, and may be wrapped around either or both ofring 231 andholder 232. As previously described in the context of suture thread holders,non-thread wrap 235 may be wrapped a single time aroundring 231 and/orholder 232, or looped multiple times around either or both structures. - Other holder architectures may also be used.
FIG. 24 shows a sheath holder including a tube structure 242 which fits aroundannuloplasty ring 241, and which can slide on and off ofannuloplasty ring 241. The sheath holder may be used with either a C-shaped ring or a gapped full-ring, a gap being required to allow the sheath holder to be removed from the ring, Tube structure 242 may be rigid, to help maintain the shape of the ring. Alternatively, tube structure 242 may be flexible or unshaped. Such a flexible holder may be especially useful in minimally invasive surgery, in which the annuloplasty ring and holder may have to be implanted through an implantation catheter. A flexible holder may permit the physician to collapse the ring and holder into the implantation catheter, in order to bring them to the implantation site. The ring and holder assembly may regain its shape once withdrawn from the implantation catheter at or near the implantation site. During implantation of a ring mounted in a sheath holder, the ring may have to be withdrawn from the holder before suturing the ring at its implant site. The suturing may be done after removal of the holder. The suturing may also be done as the sheath holder is withdrawn, so as to keep unsutured portions of the ring secured and supported in the holder while sutures are tied to exposed portions of the ring. - Annuloplasty rings mounted on holders such as the holders described herein may be mounted with pre-stitched sutures.
FIG. 25a showsring 251 attached toholder 250, with pre-stitched suture threads 252 extending fromsuture needles 253 throughring 251. The use of pre-stitched sutures 252 andneedles 253 may facilitate and accelerate the suturing of the ring at the implant site. Their use may also allow for better alignment and spacing of the sutures, ensuring better placement of the ring. Anti-entanglement features may be incorporated with the pre-stitched sutures. Suture threads 252 may pass throughholder 250, or may be used to secure or holdring 251 toholder 250. Suture threads 252 may also not pass throughholder 250, and may not be used to securering 251 toholder 250.FIG. 25b showsring 251 sutured at the implant site bysutures 253.Sutures 253 may be tied whilering 251 is still attached toholder 250, or after the holder is removed from the ring.
The invention further relates to the following numbered items: - 1. An apparatus for holding and supporting an annuloplasty ring comprising:
- an outer bracket, the annuloplasty ring being supported by said outer bracket, and said outer bracket having a saddle shape.
- 2. An apparatus for holding and supporting an annuloplasty ring comprising:
- an outer bracket, the annuloplasty ring being supported by said outer bracket; and
- a connector attached to said outer bracket, the connector comprising an attachment site for attachment of a grasping device and being placed in such a way as to have a central hole in the bracket,
said hole providing a view through the interior of the annuloplasty ring and holder.
- 3. An apparatus for holding and supporting an annuloplasty ring comprising:
- an outer bracket, the annuloplasty ring being supported by said outer bracket; and
- identifiers on the outer bracket, said identifiers indicating preferred locations of particular implant site features with respect to the bracket.
- 4. An apparatus for holding and supporting an annuloplasty ring comprising:
- an outer bracket, the annuloplasty ring being supported by said outer bracket, said outer bracket comprising an upper surface and a lower surface; and
- a connector attached to said outer bracket, the connector comprising an attachment site for attachment of a grasping device, said attachment site facing the upper surface of the outer bracket, said connector further comprising:
- a connector base that is recessed into the holder bracket, said connector base protruding further down than the outer bracket's lower surface.
- 5. An apparatus for holding and supporting an annuloplasty ring comprising:
- an outer bracket, the annuloplasty ring being supported by said outer bracket, said outer bracket comprising an upper surface and a lower surface; and
- a cutting block, said cutting block being located on outer bracket's upper surface, and being recessed into the outer bracket such that the cutting block protrudes further down than the outer bracket's lower surface.
- 6. An apparatus for holding and supporting an annuloplasty ring comprising:
- an outer bracket, the annuloplasty ring being supported by said outer bracket; and
- a cutting block located on said outer bracket, the cutting block comprising a slit for guiding a scalpel blade, said slit being shaped to match a particular type of scalpel blade.
- 7. The apparatus of item 6 wherein the cutting block slit is further shaped to provide a preferred cutting direction.
- 8. The apparatus of item 6 wherein the cutting block slit is further shaped to draw the cutting action of a scalpel traversing the slit substantially away from tissue surrounding the cutting block.
- 9. An apparatus for holding and supporting an annuloplasty ring comprising:
- an outer bracket, the annuloplasty ring being supported by said outer bracket; and
- a knot tying post located on said outer bracket, said knot tying post being used to tie a suture thread to the bracket, said suture thread being used to attach the annuloplasty ring to the holder.
- 10. An apparatus for holding and supporting an annuloplasty ring comprising:
- an outer bracket, the annuloplasty ring being supported by said outer bracket; and
- suture channels on said outer bracket, said suture channels being traversed by suture thread used to tie the annuloplasty ring to the outer bracket.
- 11. An apparatus for holding and supporting an annuloplasty ring comprising:
- an outer bracket, the annuloplasty ring being supported by said outer bracket; and
- suture thread attached to the outer bracket and stitched through the annuloplasty ring to tie the annuloplasty ring to the outer bracket.
- 12. An apparatus for holding and supporting an annuloplasty ring comprising:
- an outer bracket, the annuloplasty ring being supported by said outer bracket; and
- suture thread wrapped around said annuloplasty ring to tie the annuloplasty ring to the outer bracket.
- 13. The apparatus defined in item. 12 further comprising a mechanism for releasing said suture thread, the releasing being done without requiring the use of a scalpel.
- 14. An apparatus for holding and supporting an annuloplasty ring comprising:
- an outer bracket, the annuloplasty ring being supported by said outer bracket; and
- at least one length of suture thread that is wrapped multiple time around the annuloplasty ring to tie the annuloplasty ring to the outer bracket.
- 15. An apparatus for holding and supporting a C-shaped annuloplasty ring comprising:
- an outer bracket, the annuloplasty ring being supported by said outer bracket; and
- clamps attached to outer bracket for engaging the ends of the annuloplasty ring to secure the ring to the outer bracket.
- 16. An apparatus for holding and supporting an annuloplasty ring comprising:
- an outer bracket, the annuloplasty ring being supported by said outer bracket; and
- rods that protrude from the outer bracket, said rods applying pressure at a plurality of points on the annuloplasty ring's inner surface to secure the annuloplasty ring to the outer bracket.
- 17. An apparatus for holding and supporting an annuloplasty ring comprising:
- an outer bracket, the annuloplasty ring being supported by said outer bracket, said outer bracket comprising at least one inner brace and one peripheral brace; and
- peripheral braces for securing the annuloplasty ring to the outer bracket by clamping the ring between the bracket and the peripheral braces at a plurality of locations around the ring's periphery.
- 18. The apparatus defined in
item 17 wherein the braces substantially surround the ring at said locations. - 19. An apparatus for holding and supporting an annuloplasty ring comprising;
- a tube structure within which the annuloplasty ring can be placed, the annuloplasty ring being supported by said tube structure, and the annuloplasty ring being withdrawn from the tube structure concurrently with its being sutured at an implant site.
- 20. An apparatus for holding and supporting an annuloplasty ring comprising:
- an outer bracket, the annuloplasty ring being supported by said outer bracket; and
- pre-stitched sutures tied to the annuloplasty ring said sutures to be used in securing the ring at the implant site.
Claims (13)
- An apparatus for holding and supporting an annuloplasty ring comprising:an outer bracket, the annuloplasty ring being supported by said outer bracket, and the outer bracket includes a plurality of c-shaped braces (161, 171) arranged to support the annuloplasty ring; anda central holding structure including a release mechanism configured to draw the c-shaped braces inwards towards the central holding structure and release the annuloplasty ring from the apparatus.
- The apparatus according to claim 1, wherein each c-shaped brace of the plurality of c-shaped braces is attached to the central holding structure by way of a radial bracket support arm (162, 172) and the release mechanism is further configured to draw the c-shaped braces inwards by moving the radial bracket support arms.
- The apparatus according to claim 1, wherein each particular c-shaped brace of the plurality of c-shaped braces is attached to the central holding structure by way of an upper radial bracket support arm and a lower radial support arm (162, 172) and the release mechanism is further configured to draw the particular c-shaped brace inward by moving the upper radial bracket support arm in a first direction and moving the lower radial bracket support arm in a second direction different from the first direction.
- The apparatus according to claim 2, wherein the release mechanism is configured such that the first direction is a substantially upwards direction and the second direction is a substantially downwards direction.
- The apparatus according to claim 1, wherein each particular c-shaped brace of the plurality of c-shaped braces is attached to the central holding structure by way of an upper radial bracket support arm and a lower radial support arm (162, 172) and the release mechanism is further configured to draw the particular c-shaped brace inward by moving the upper and lower radial bracket support arms in substantially opposite directions.
- The apparatus of anyone of claims 1-5, wherein each c-shaped brace of the plurality of c-shaped braces includes beveled edges that support the annuloplasty ring when the braces are extended radially outwardly from the central holding structure.
- The apparatus of anyone of claims 1-6, wherein the plurality of c-shaped braces include serrated jaws (182).
- The apparatus of anyone of claim 7, wherein the serrated jaws are hinged to clamp and hold the ring.
- The apparatus of anyone of claims 1-6, wherein the plurality of c-shaped braches include clipping brackets (182).
- The apparatus of anyone of claims 1-6, wherein the plurality of c-shaped braces include a high-friction surface configured to further secure the annuloplasty ring in the outer bracket.
- The apparatus of anyone of claims 1-10, wherein the release mechanism includes a push-button release.
- The apparatus of anyone of claims 1-10, wherein the release mechanism includes an operating lever.
- The apparatus of anyone of claims 1-12, wherein the outer bracket is configured to support a c-shaped annuloplasty ring.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
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US57102004P | 2004-05-14 | 2004-05-14 | |
EP05750482.1A EP1761211B1 (en) | 2004-05-14 | 2005-05-12 | Apparatus for holding and supporting an annuloplasty ring |
Related Parent Applications (2)
Application Number | Title | Priority Date | Filing Date |
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EP05750482.1 Division | 2005-05-12 | ||
EP05750482.1A Division EP1761211B1 (en) | 2004-05-14 | 2005-05-12 | Apparatus for holding and supporting an annuloplasty ring |
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EP2433591A2 true EP2433591A2 (en) | 2012-03-28 |
EP2433591A3 EP2433591A3 (en) | 2014-05-07 |
EP2433591B1 EP2433591B1 (en) | 2016-04-27 |
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Application Number | Title | Priority Date | Filing Date |
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EP11194544.0A Not-in-force EP2433591B1 (en) | 2004-05-14 | 2005-05-12 | Apparatus for holding an annuloplasty ring |
EP05750482.1A Not-in-force EP1761211B1 (en) | 2004-05-14 | 2005-05-12 | Apparatus for holding and supporting an annuloplasty ring |
Family Applications After (1)
Application Number | Title | Priority Date | Filing Date |
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EP05750482.1A Not-in-force EP1761211B1 (en) | 2004-05-14 | 2005-05-12 | Apparatus for holding and supporting an annuloplasty ring |
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US (1) | US8052748B2 (en) |
EP (2) | EP2433591B1 (en) |
JP (1) | JP2007537794A (en) |
ES (1) | ES2436399T3 (en) |
WO (1) | WO2005112832A1 (en) |
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- 2005-05-12 US US11/128,872 patent/US8052748B2/en not_active Expired - Fee Related
- 2005-05-12 WO PCT/US2005/017490 patent/WO2005112832A1/en active Application Filing
- 2005-05-12 JP JP2007513484A patent/JP2007537794A/en not_active Withdrawn
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Also Published As
Publication number | Publication date |
---|---|
EP2433591B1 (en) | 2016-04-27 |
WO2005112832A1 (en) | 2005-12-01 |
US20050267572A1 (en) | 2005-12-01 |
EP1761211B1 (en) | 2013-08-28 |
ES2436399T3 (en) | 2013-12-30 |
JP2007537794A (en) | 2007-12-27 |
EP1761211A1 (en) | 2007-03-14 |
US8052748B2 (en) | 2011-11-08 |
EP2433591A3 (en) | 2014-05-07 |
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